Instructions for use GENTLEpower LUX Contra-angle 25 LP - REF

Transcription

1 Instructions for use GENTLEpower LUX Contra-angle 25 LP - REF

2 Distributed by: KaVo Dental GmbH Bismarckring 39 D Biberach Phone Fax Manufacturer: Kaltenbach & Voigt GmbH Bismarckring 39 D Biberach

3 Contents 1 Contents 1 User instructions Safety Description of safety instructions Description of safety instructions: Warning symbol Description of safety instructions: Structure Description of safety instructions: Description of danger levels Safety instructions Product description Purpose Intended use Technical data Transportation and storage conditions... 21

4 Contents 2 4 Start up and shut down Checking the amount of water Operation Attach the medical device Remove the medical device Insert the milling cutters or diamond grinders Removing the milling tool or diamond grinder Troubleshooting Check for malfunctions Troubleshooting Troubleshooting: Replacing the O-rings Troubleshooting: Cleaning the spray nozzle Troubleshooting: Change the water filter... 40

5 Contents 3 7 Reconditioning methods according to ISO Preparations at the site of use Cleaning Cleaning: Manual cleaning - external Cleaning: Automated external cleaning Cleaning: Manual cleaning of the inside Cleaning: Automated internal cleaning Disinfection Disinfection: Manual disinfection - external Disinfection: Manual disinfection - internal Disinfection: Machine disinfection - external and internal Drying Care products and systems - Servicing Care products and systems - Servicing: Servicing with KaVo Spray... 53

6 Contents Care products and systems - Servicing: Care of the KaVo SPRAYrotor Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS Packaging Sterilisation Storage Tools and consumables Terms and conditions of warranty... 69

7 User instructions 5 1 User instructions Dear User Congratulations on purchasing this KaVo quality product. By following the instructions below you will be able to work smoothly, economically and safely. Copyright by KaVo Dental GmbH Symbols Refer to the chapter on Safety/Warning symbol Important information for users and service technicians

8 User instructions 6 Action request CE mark (European Community). A product bearing this mark meets the requirements of the applicable EC directive. Can be steam-sterilised at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 F) Thermodisinfectable Target group This document is intended for dentists and their assistants. The section on starting up is also intended for service technicians.

9 Safety 7 2 Safety Description of safety instructions: Warning symbol Warning symbol Description of safety instructions: Structure DANGER The introduction describes the type and source of the hazard. This section describes the potential consequences of non-observance. The optional step includes necessary measures for hazard prevention.

10 Safety Description of safety instructions: Description of danger levels The safety instructions listed here, together with the three levels of danger will help avert property damage and injury. CAUTION CAUTION indicates a hazardous situation that can cause damage to property or mild to moderate injuries. WARNING WARNING indicates a hazardous situation that can cause death or serious injury.

11 Safety 9 DANGER DANGER indicates a hazardous situation that can directly cause death or serious injury. 2.2 Safety instructions WARNING Hazards for the care provider and the patient. In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held. Do not use further and notify Service.

12 Safety 10 CAUTION Burning hazard from hot instrument head and instruments cover. If the instrument overheats, burns may arise in the oral area. Never contact soft tissue with the instrument head. CAUTION Hazard from use as a light probe. Do not use the device as a light probe since the rotating cutters or grinders can cause injury. Use an appropriate light probe for additional illumination of the oral cavity or site of preparation.

13 Safety 11 CAUTION Risk due to incorrectly stored instrument. Damage to clamping system from dropping the instrument. After treatment, place the instrument properly in the cradle without the tool.

14 Safety 12 CAUTION Risks due to lack of control equipment. Hazards can arise if control equipment is not available for changing the speed and the direction of rotation. The dental treatment unit connected must have control equipment for changing the speed and direction of rotation. A note is to be included in the documents accompanying the dental treatment unit, referring to responsibilities arising from safety, reliability and performance. The medical device may only be combined with a treatment centre released by KaVo.

15 Safety 13 CAUTION Premature wear and malfunctioning from improper storage during long periods of nonuse. Reduced product life. The medical device should be cleaned, serviced and stored in a dry location, according to instructions, before long periods of nonuse.

16 Safety 14 CAUTION Hazard from the use of handpieces equipped with electronic micromotors. Electronic micromotors generate much more energy than conventional pneumatic turbines and motors. Given the higher torque and speed, handpieces that are poorly serviced, damaged or used improperly can overheat which can cause serious burn injuries to the patient. Observe the following points.

17 Safety 15 The following guidelines must be observed to ensure save use of the electrically driven handpieces: The service instructions for handpieces must be precisely following when using KAVO spray or QUATTROcare care systems. Before each use, the handpiece must be checked for external damage. Before each use, perform a test run with the handpiece, and watch for atypical heating and unusual noise and vibration. Immediately stop using handpieces that act unusual. Never press the pushbutton during operation. This also includes lifting the cheek or tongue! Note For safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires.

18 Safety 16 The following individuals are authorized to repair and service KaVo products: Technicians at KaVo branches throughout the world Technicians specially trained by KaVo To ensure proper function, the medical device must be set up according to the reprocessing methods described in the KaVo Instructions for Use, and the care products and care systems described therein must be used. KaVo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device. This service interval depends on the frequency of use and should be adjusted accordingly. Service may only be carried out by KaVo-trained repair shops using original KaVo replacement parts.

19 Product description 17 3 Product description GENTLEpower LUX contra-angle 25 LP (Mat. no )

20 Product description Purpose Intended use Purpose: This medical device is Only intended for dental treatment. Any other type of use or alteration to the product is impermissible and can be hazardous. The medical device is intended for the following uses: Removal of carious material, cavities and crown preparations, removal of fillings, processing of tooth and restoration surfaces. A medical device according to relevant national statutory regulations.

21 Product description 19 Proper use: According to these regulations, this medical device may only be used for the described application by a knowledgeable user. The following must be observed: the applicable health and safety regulations the applicable accident prevention regulations these instructions for use According to these regulations, it is the responsibility of the user to: only use equipment that is operating correctly, use the equipment for the proper purpose, protect him or herself, the patient and third parties from danger, and avoid contamination from the product.

22 Product description Technical data Drive speed Speed transmission 1:5 Identification Pushbutton chuck max. 40,000 rpm 1 red ring Usable with contra-angle cutters or grinders. 1.6 mm diam. The contra-angle handpiece can be mounted on all INTRAmatic Lux motors, and motors with a connection in accordance with ISO 3964 / DIN

23 Product description Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored strongly refrigerated. This can cause the medical device to malfunction. Prior to start-up, very cold products must be heated to a temperature of 20 C to 25 C (68 F to 77 F). Temperature: -20 C to +70 C (-4 F to +158 F) Relative humidity: 5% RH to 95% RH absence of condensation

24 Product description 22 Air pressure: 700 hpa to 1060 hpa (10 psi to 15 psi) Protect from moisture

25 Start up and shut down 23 4 Start up and shut down WARNING Hazard from nonsterile products. Infection danger to the care provider and patient. Before first use and after each use, prepare and sterilise the medical device if needed. WARNING Disposal of the product in the appropriate manner. Prior to disposal, the product must be appropriately prepared or sterilised if this is necessary.

26 Start up and shut down 24 CAUTION Damage from contaminated and moist cooling air. Contaminated and moist cooling air can cause malfunctions. Make sure that the supply of cooling air is dry, clean, and uncontaminated according to EN ISO

27 Start up and shut down Checking the amount of water CAUTION Overheating of the tooth due to insufficient amount of cooling water. Insufficient spray water can cause the medical device to overheat and damage the pulp and tooth. Adjust the water amount for the spray cooling to a minimum of 50 cm 3 /min (3.1 inch 3 ). Check spray water channels and if necessary clean spray nozzles with the nozzle needle (Mat. no ). Check water filter and replace, if necessary.

28 Operation 26 5 Operation 5.1 Attach the medical device WARNING Release of the medical device during treatment. A medical device that is not properly locked in place can release from the motor coupling and fall off. Carefully pull on it before each treatment to ensure that the medical device is securely locked on the motor coupling.

29 Operation 27 CAUTION Connect to the drive motor. Contra-angle handpiece blocked. Only start the contra-angle handpiece when the chuck is closed. CAUTION Removing and attaching the contra-angle handpiece while the drive motor is rotating. Damage to the drive. Never attach or remove the contra-angle handpiece while the drive motor is rotating!

30 Operation 28 CAUTION Damage If the footswitch is pressed while you are connecting and removing the medical device, you can damage the medical device and motor coupling. Do not connect or remove the medical device while pressing the footswitch. Lightly spray O-rings on motor coupling with Mehrfunktionsspritze Spray.

31 Operation 29 Attach the medical device to the motor coupling and turn it until the guide stud audibly snaps into place. Pull on the medical device to make sure that it is securely affixed to the coupling.

32 Operation Remove the medical device Unlock the medical device from the motor coupling by twisting it slightly and then pulling it along its axis. 5.3 Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond grinders that comply with EN ISO type 3, are made of steel or hard metal and meet the following criteria: - Shaft diameter: 1.59 to 1.60 mm - Overall length: max. 25 mm - Shaft clamping length: at least 11 mm - Blade diameter: max. 2 mm

33 Operation 31 CAUTION Use of unauthorised cutters or grinders. Injury to the patient or damage to the medical device. Observe the instructions for use and use the cutter or grinder properly. Only use cutters or grinders that do not deviate from the specified data. CAUTION Injury from using worn drill bits or burs. Drill bits or burs could fall out during treatment and injure the patient. Never use drill bits or burs with worn shafts.

34 Operation 32 CAUTION Injury hazard from cutters or grinders. Infections or cuts. Wear gloves or fingerstalls. CAUTION Hazard from defective chucking system. The cutter or grinder could fall out and cause injury. Pull on the cutter or grinder to check that the chucking system is okay and the cutter or grinder is securely held. When checking, inserting and removing, use gloves or a fingerstall to prevent an injury or infection.

35 Operation 33 Forcefully press the push button with your thumb and simultaneously insert the cutter or grinder all the way. Check that the cutter or grinder is seated by pulling on it.

36 Operation Removing the milling tool or diamond grinder WARNING Hazard from rotating cutter or grinder. Lacerations and damage to the chucking system. Do not touch rotating cutter or grinder.! Never press the press-button while the cutter or grinder is rotating! Remove the cutter or grinder from the contra-angle handpiece after treatment to avoid injury or infection while storing it.

37 Operation 35 After the cutter or grinder has stopped rotating, press the press-button with your thumb and simultaneously pull out the drill bit or bur.

38 Troubleshooting 36 6 Troubleshooting 6.1 Check for malfunctions CAUTION Missing or damaged O-rings. Malfunctions and premature failure. Make sure that all O-rings are on the coupling and undamaged. CAUTION Heating of the product. Burns or product damage from overheating. Do not use the product if it is irregularly heated.

39 Troubleshooting 37 The medical device is too hot while idling: Check the amount of cooling air. The medical device is too hot while working: Caring for the medical device. When the speed drops or is uneven: Caring for the medical device. An O-ring is missing on the motor coupling: Replace O-ring Troubleshooting: Replacing the O-rings CAUTION Hazard from improper care of the O-rings. Malfunctions or complete failure of the medical device. Do not use Vaseline or other grease or oil.

40 Troubleshooting 38 Note The O-ring on the coupling may only be lubricated with a cotton ball wet with KAVO spray. Press the O-ring between your fingers to form a loop. Shove the O-ring to the front, and remove it. Insert new O-rings into the grooves.

41 Troubleshooting Troubleshooting: Cleaning the spray nozzle. CAUTION Hazard from insufficient spray water. Overheating of the medical device and damage to the tooth. Check the spray water channels and clean the spray nozzles with the nozzle needle Mat. no if necessary. Check the water filter and exchange if necessary. Use the nozzle needle (Mat. no ) to free the water passage in the spray nozzles.

42 Troubleshooting Troubleshooting: Change the water filter Screw out and remove the filter with the wrench (Mat. no ). Insert the new filter (Mat. no ) and screw it in with the wrench.

43 Reconditioning methods according to ISO Reconditioning methods according to ISO Preparations at the site of use WARNING Hazard from nonsterile products. There is a risk of infection from contaminated medical devices. Take suitable personal protective measures. Remove all residual cement, composite or blood without delay. Recondition the medical device as soon as possible after treatment. Remove the cutter or grinder from the medical device. The medical device must be dry when transported for reconditioning. Do not place it in a solution or similar.

44 Reconditioning methods according to ISO Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. Only clean manually or in a thermodisinfector Cleaning: Manual cleaning - external Accessories required: Tap water 30 C ± 5 C (86 F ± 10 F) Brush, e.g. medium-hard toothbrush

45 Reconditioning methods according to ISO Brush off under flowing tap water Cleaning: Automated external cleaning KaVo recommends thermodisinfectors in accordance with EN ISO , which are operated with alkaline cleaning agents with a ph value of max. 10 (e.g. Miele G 7781 / G 7881 Validation was carried out with Programme "VARIO-TD", cleaning agent "neodisher mediclean", neutralisation agent "neodisher Z" and rinsing agent "neodisher mielclear" and only applies to the material compatibility with KaVo products).

46 Reconditioning methods according to ISO For program settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the thermodisinfector (complying with max. ph value of 10). In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry, and then lubricate immediately with care agents from the KaVo care system Cleaning: Manual cleaning of the inside Can only be done with KaVo CLEANspray or KaVo DRYspray. Cover the medical device with the KaVo CLEANpac bag, and place it on the corresponding care adapter. Press the spray button three times for 2 seconds each time. Remove the medical device from the spray attachment and let the cleaner work for one minute.

47 Reconditioning methods according to ISO Afterwards, rinse for 3-5 seconds with KaVo DRYspray. See also: KaVo CLEANspray / KaVo DRYspray Instructions for Use Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the following countries: Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxembourg, Belgium, Netherlands, United Kingdom, Denmark, Sweden, Finland and Norway. In other countries interior cleaning can only be carried out with thermodisinfectors in accordance with EN ISO

48 Reconditioning methods according to ISO Cleaning: Automated internal cleaning KaVo recommends thermodisinfectors in accordance with EN ISO , which are operated with alkaline cleaning agents with a ph value of max. 10 (e.g. Miele G 7781 / G 7881 Validation was carried out with Programme "VARIO-TD", cleaning agent "neodisher mediclean", neutralisation agent "neodisher Z" and rinsing agent "neodisher mielclear" and only applies to the material compatibility with KaVo products). For program settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the thermodisinfector (complying with max. ph value of 10).

49 Reconditioning methods according to ISO In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry, and then lubricate immediately with care agents from the KaVo care system. 7.3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. Defects in the product. Only disinfect in a thermodisinfector or manually.

50 Reconditioning methods according to ISO Disinfection: Manual disinfection - external KaVo recommends the following products based on material compatibility. The microbiological efficacy must be ensured by the disinfectant manufacturer. Mikrozid AF Liquid made by Schülke & Mayr FD 322 made by Dürr CaviCide made by Metrex Consumables required: Cloths for wiping off the medical device.

51 Reconditioning methods according to ISO Spray the disinfectant on a cloth, then thoroughly wipe down the medical device and leave the disinfectant to soak in according to the instructions from the disinfectant manufacturer. Follow the instructions for use of the disinfectant Disinfection: Manual disinfection - internal The efficacy of manual internal disinfection must be demonstrated by the manufacturer of the disinfection agent. With KaVo products, use only disinfection agents that have been released by KaVo with respect to the compatibility of materials (e.g. WL-cid / made by ALPRO). Follow the instructions for use of the disinfectant.

52 Reconditioning methods according to ISO Immediately after internal disinfection, lubricate the KaVo medical device immediately with care agents from the KaVo care system Disinfection: Machine disinfection - external and internal KaVo recommends thermodisinfectors in accordance with EN ISO , which are operated with alkaline cleaning agents with a ph value of max. 10 (e.g. Miele G 7781 / G 7881 Validation was carried out with Programme "VARIO-TD", cleaning agent "neodisher mediclean", neutralisation agent "neodisher Z" and rinsing agent "neodisher mielclear" and only applies to the material compatibility with KaVo products). For program settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the thermodisinfector (complying with max. ph value of 10).

53 Reconditioning methods according to ISO In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry, and then lubricate immediately with care agents from the KaVo care system. 7.4 Drying Manual Drying Blow off the outside and inside with compressed air until water drops are no longer visible. Automatic Drying The drying procedure is normally part of the cleaning program of the thermodisinfector.

54 Reconditioning methods according to ISO Follow the instructions for use of the thermodisinfector. 7.5 Care products and systems - Servicing WARNING Sharp cutters or grinders in the medical device. Risk of injury from sharp or pointed cutters or grinders. Remove cutter or grinder. CAUTION Premature wear and malfunctions from improper servicing and care. Reduced product life. Perform proper care regularly!

55 Reconditioning methods according to ISO Note KaVo only guarantees that its products will function properly when the care products used are those listed as accessories, as they were tested for proper use on our products Care products and systems - Servicing: Servicing with KaVo Spray KaVo recommends servicing the product after each time it is used, i.e. after each automatic cleaning and before each sterilisation. Remove cutter or grinder.

56 Reconditioning methods according to ISO Cover the product with the CLEANpac bag. Place the product on the cannula and press the spray button for one second. Care of chucking system KaVo recommends cleaning and servicing the chuck system once a week. Remove the cutter or grinder, place the spray nipple tip in the opening and spray.

57 Reconditioning methods according to ISO Carry out the servicing according to the instructions in the section, "Care with KaVo Spray" Care products and systems - Servicing: Care of the KaVo SPRAYrotor KaVo recommends servicing the product after each time it is used, i.e. after each automatic cleaning and before each sterilisation. Place the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a CLEANpac bag. Service the product. See also: Instructions for use KaVo SPRAYrotor

58 Reconditioning methods according to ISO Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A Cleaning and care unit with expansion pressure for effective cleaning and care. KaVo recommends servicing the product after each time it is used, i.e. after each automatic cleaning and before each sterilisation. Remove the cutter or grinder. Servicing the product.

59 Reconditioning methods according to ISO Servicing the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week. See also: Instructions for use KaVo QUATTROcare 2104 / 2104A Remove the cutter or grinder, place the spray nipple tip in the opening and spray.

60 Reconditioning methods according to ISO Subsequently treat with the care products and care systems specified. See also: Servicing with KaVo QUATTROcare 2104 / 2104A Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS KaVo recommends servicing the product after each time it is used, i.e. after each automatic cleaning and before each sterilisation. Remove the cutter or grinder. Servicing the product in QUATTROcare PLUS. See also: Instructions for use KaVo QUATTROcare PLUS

61 Reconditioning methods according to ISO Servicing the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week. See also: Instructions for use KaVo QUATTROcare PLUS Note Switch on the chuck service mode. No handpieces may be on the treatment coupling at the start of and during the chuck service mode. Close the front flap and press the chuck service button 4 for at least three seconds until the spray canister control LED 1 flashes three times consecutively. The QUATTROcare is now in chuck service mode.

62 Reconditioning methods according to ISO Remove the service coupling chuck from the side hatch of the QUATTROcare PLUS and attach it to coupling service point four, on the far right. A MULTIflex adapter must be mounted there. Press the handpiece together with the guide bush of the chuck to be serviced against the tip of the service coupling chuck. Press the button showing the chuck service symbol.

63 Reconditioning methods according to ISO Note Completing the chuck service mode. Option 1: Equipping the QUATTROcare with handpieces and closing the front panel. Option 2: after three minutes without a service procedure, the device switches automatically to normal service mode. See also: Care with KaVo QUATTROcare PLUS

64 Reconditioning methods according to ISO Packaging Note The sterilisation bag must be large enough for the handpiece so that the bag is not stretched. The quality and use of the sterilisation packaging must satisfy applicable standards and be suitable for the sterilisation procedure! Individually seal the medical device in the sterilised item packaging.

65 Reconditioning methods according to ISO Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with EN / ISO (e.g. KaVo STERIclave B 2200 / 2200 P) CAUTION Premature wear and malfunctions from improper servicing and care. Reduced product life. Before each sterilisation cycle, service the medical device with Ka Vo care products.

66 Reconditioning methods according to ISO CAUTION Contact corrosion due to moisture. Damage to product. Immediately remove the product from the steam steriliser after the sterilisation cycle! The KaVo medical device has a maximum temperature resistance up to 138 (280.4 F).

67 Reconditioning methods according to ISO (Depending on the available autoclave,) select a suitable procedure from the following sterilisation processes: Autoclave with three times initial vacuum: at least 3 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 F) Autoclave using the gravitation method: at least 10 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 F) or alternatively at least 60 minutes at 121 C -1 C / +4 C (250 F -1.6 F / +7.4 F) Use according to the manufacturer's Instructions for Use.

68 Reconditioning methods according to ISO Storage Reprocessed products should be stored protected from dust with minimum exposure to germs in a dry, dark and cool space. Comply with the expiry date of the sterilised items.

69 Tools and consumables 67 8 Tools and consumables Available from dental suppliers. Material summary Mat. no. Instrument stand Cellulose pad 100 units Cleanpac 10 units Nozzle needle Replacement filter Wrench O-ring

70 Tools and consumables 68 Material summary Mat. no. Adaptor INTRAmatic (CLEANspray and DRYspray) KaVo CLEANspray 2110 P KaVo DRYspray 2117 P KaVo Spray 2112 A ROTAspray A QUATTROcare plus Spray 2140 P

71 Terms and conditions of warranty 69 9 Terms and conditions of warranty The following warranty conditions apply to this KaVo medical device: KaVo provides the end customer with a warranty of proper function and guarantees zero defects in respect of material and processing for a period of 24 months from the date of the invoice, subject to the following conditions: In case of justified complaints, KaVo will honour its warranty with a free replacement or repair. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded. In the event of default, gross negligence or intent, this shall only apply in the absence of mandatory legal regulations to the contrary. KaVo shall not be liable for defects and their consequences that have arisen or may arise from natural wear, improper handling, cleaning or maintenance, non-compliance with operating, maintenance or connection instructions, calcination or corrosion, contaminated air or water supplies

72 Terms and conditions of warranty 70 or chemical or electrical factors deemed abnormal or impermissible in accordance with KaVo's instructions for use or other manufacturer's instructions. The warranty granted does not usually extend to lamps, light conductors made of glass and glass fibres, glassware, rubber parts, and the colourfastness of plastic parts. All liability is excluded if defects or their consequences originate from manipulations or changes to the product made by the customer or a third party that is not authorised by KaVo. Warranty claims will only be accepted if the product is submitted along with proof of purchase in the form of a copy of the invoice or note of delivery. The dealer, purchase date, type, and serial number must be clearly evident from this document.

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